This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

Team-NB has shared proposals for how to stop “lengthy debates” between manufacturers and notified bodies about the applicability of a rule about the need for clinical data on medical devices.

PITTSBURGH — Is it worth agreeing to an early orientation meeting with the US Food and Drug Administration (FDA) about your medical device software? Alex Cadotte, vice president of Digital Health, AI, ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week ...

Artificial intelligence (AI) is already writing code, generating requirements, and suggesting test cases — but how do RA/QA teams maintain oversight when these tools operate inside regulated workflows ...